Efficacy and Safety Study With MYL-1401H and Neulasta

NCT02467868 | Completed Phase 3

• 2 other identifiers: MYL-1401H-30012014-002324-27
• Study Type: interventional
• Target: 193
• Locations: 6 countries
• Sites: 36

Brief Summary

This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy.

Conditions

Breast Neoplasms; Chemotherapy-Induced Febrile Neutropenia

Keywords

Pegfilgrastim; Granulocyte Colony Stimulating Factor (G-CSF); Breast Cancer; Neutropenia

Outcome Measures

Primary Outcomes (1)

• Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L

  Cycle 1 of chemotherapy (approx 21 days)

Secondary Outcomes (1)

• The rate of febrile neutropenia (FN)

  Week 24 (End of the study)

Other Outcomes (2)

• Incidence, nature, and severity of adverse events (AEs)

  Week 24

• Presence of antibodies against MYL-1401H and Pegfilgrastim

  Week 24

Study Arms (2)

MYL-1401H

EXPERIMENTAL

MYL-1401H

Biological: MYL-1401H

Neulasta

ACTIVE COMPARATOR

Neulasta

Biological: Neulasta

Interventions

MYL-1401H BIOLOGICAL

During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.

Also known as: Pegfilgrastim, Recombinant human granulocyte colony-stimulating factor (G-CSF)

MYL-1401H

Neulasta BIOLOGICAL

During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.

Also known as: Pegfilgrastim, Recombinant human granulocyte colony-stimulating factor (G-CSF)

Neulasta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent.
• Patients ≥18 years.
• Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug.
• Newly diagnosed, pathologically confirmed breast cancer.
• Stage II or III breast cancer with adequate staging workup and adequate surgery if receiving adjuvant therapy.
• Patients planned/eligible to receive neoadjuvant or adjuvant treatment with (Docetaxel, Doxorubicin, Cyclophosphamide \[TAC\]) for their breast cancer.
• Cancer Chemotherapy and Radiotherapy naïve.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Absolute neutrophil count ≥ 1.5 × 109/L ; Platelet count ≥ 100 × 109/L ;
• Hemoglobin \> 10 g/dL without blood transfusions or cytokine support during the two weeks previous to the hemoglobin level.
• Adequate cardiac function (including left ventricular ejection fraction ≥ 50% as assessed by echocardiography) within 4 weeks prior to start of chemotherapy.
• Adequate renal function, i.e., creatinine \< 1.5 × upper limit of normal (ULN).

You may not qualify if:

• Participation in a clinical trial in which they received an investigational drug within 28 days before randomization.
• Previous exposure to filgrastim, pegfilgrastim, lenograstim, lipegfilgrastim, or other filgrastim forms on the market or in clinical development.
• Received blood transfusions or erythroid growth factors within 2 weeks prior to first dose of chemotherapy.
• Known hypersensitivity to any drugs or excipients that patients will be receiving during the study.
• Known hypersensitivity to E. coli-derived products.
• Known fructose intolerance (related with sorbitol excipient).
• Underlying neuropathy of grade 2 or higher.
• Active infectious disease or any other medical condition which might put the patient at significant risk to tolerate 6 courses of TAC chemotherapy (e.g., recent myocardial infarction).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × Upper limit of normal (ULN), ALT and/or AST \> 1.5 × ULN with alkaline phosphatase (ALP) \> 2.5 × ULN; any bilirubin \> ULN.
• Treatment with systemically active antibiotics within 5 days before first dose of chemotherapy.
• Patients under treatment with lithium.
• Chronic use of oral corticosteroids.
• Splenomegaly of unknown origin by physical examination and/or computerized tomography scan or ultrasound and any condition which can cause splenomegaly, e.g., thalassemia, glandular fever, hemolytic anemias, and malaria.
• Myeloproliferative or myelodysplastic disorders, sickle cell disorders, and any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
• Increase potential risk of Adult Respiratory Distress Syndrome.

Sponsors & Collaborators

• Mylan Inc.: lead
• Mylan GmbH: collaborator

Study Sites (36)

Mylan Investigational Site 3502

Plovdiv, Bulgaria

Location

Mylan Investigational Site 3506

Plovdiv, Bulgaria

Location

Mylan Investigational Site 3507

Plovdiv, Bulgaria

Location

Mylan Investigational Site 3503

Sofia, Bulgaria

Location

Mylan Investigational Site 3505

Sofia, Bulgaria

Location

Mylan Investigational Site 3504

Varna, Bulgaria

Location

Mylan Investigational SIte 3501

Veliko Tarnovo, Bulgaria

Location

Mylan Investigational Site 9901

Tbilisi, Georgia

Location

Mylan Investigational Site 9902

Tbilisi, Georgia

Location

Mylan Investigational Site 9903

Tbilisi, Georgia

Location

Mylan Investigational Site 9904

Tbilisi, Georgia

Location

Mylan Investigational Site 9905

Tbilisi, Georgia

Location

Mylan Investigational Site 9906

Tbilisi, Georgia

Location

Mylan Investigational Site 9907

Tbilisi, Georgia

Location

Mylan Investigational site 4905

Bonn, Germany

Location

Mylan Investigational Site 3604

Budapest, Hungary

Location

Mylan Investigational SIte 3606

Budapest, Hungary

Location

Mylan Investigational Site 3607

Budapest, Hungary

Location

Mylan Investigational Site 3609

Debrecen, Hungary

Location

Mylan Investigational Site 3601

Gyula, Hungary

Location

Mylan Investigational SIte 3605

Nyíregyháza, Hungary

Location

Mylan Investigational Site 3603

Szombathely, Hungary

Location

Mylan Investigational Site 3602

Zalaegerszeg, Hungary

Location

Mylan Investigational site 4802

Bydgoszcz, Poland

Location

Mylan Investigational Site 4805

Kościerzyna, Poland

Location

Mylan Investigational SIte 4804

Krakow, Poland

Location

Mylan Investigational SIte 3804

Chernivtsi, Ukraine

Location

Mylan Investigational site 3801

Dniepropetrovsk, Ukraine

Location

Mylan Investigational Site 3805

Dniepropetrovsk, Ukraine

Location

Mylan Investigational Site 3808

Kharkiv, Ukraine

Location

Mylan Investigational Site 3810

Kyiv, Ukraine

Location

Mylan Investigatational Site 3802

Lutsk, Ukraine

Location

Mylan Investigational SIte 3807

Lviv, Ukraine

Location

Mylan Investigational SIte 3803

Odesa, Ukraine

Location

Mylan Investigational Site 3809

Sumy, Ukraine

Location

Mylan Investigational Site 3806

Uzhhorod, Ukraine

Location

Related Publications (1)

• Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Lang I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A. Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia. Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1.

  PMID: 30824956 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Chemotherapy-Induced Febrile Neutropenia; Neutropenia

Interventions

MYL-1401H; pegfilgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Febrile Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Rasmus Rojkjaer, MD

  Mylan GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 10, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

GE (7); DE (1); PL (3); UA (10); BU (7); HU (8)